Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: questionnaires.
- Who it may be relevant to
- Registry conditions: Female Artificial Urinary Sphincter Implantation. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women
Overview
Urinary incontinence (UI) is a common and disabling condition that affects millions of people worldwide and significantly impacts the quality of life of those affected. It is well established that urinary incontinence negatively affects sexual life. Although there is no definitive consensus yet, many authors report that sexual function, after surgical intervention to restore continence, is likely to improve or, at the very least, remain unchanged.
Detailed description
The primary objective of the study is to evaluate sexual function in women 6 months after implantation of an artificial urinary sphincter.
Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.
The patients concerned are women who have undergone implantation of an artificial urinary sphincter.
Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.
Interventions
- Other questionnaires
The PISQ-12 questionnaire, which explores female sexual function; the ICIQ-FLUTSsex questionnaire, which focuses on the impact of urinary leakage on sexuality; the USP questionnaire, which assesses the frequency and characteristics of urinary incontinence; and the Qualiveen-SF questionnaire, which measures the impact of these urinary disorders on daily life. A bladder diary was completed preoperatively as well as during follow-up visits at 6 and 12 months.
Primary outcome measures
- Assess sexual function [Time frame: 6 months]
Secondary outcome measures (6)
- Assess sexual function [Time frame: 12 months]
- Assess sexual quality of life [Time frame: 6 and 12 months]
- Assess urinary incontinence (clinical efficacy) [Time frame: 6 and 12 months]
- Assess urinary incontinence (clinical efficacy) [Time frame: 6 and 12 months]
- Assess quality of life [Time frame: 6 and 12 months]
- Assess complications [Time frame: 6 and 12 months]
Eligibility criteria
Inclusion criteria
- Women aged 18 to 80 years
- Patients with from urinary incontinence with an appropriate surgical indication for artificial urinary sphincter implantation
- Patients who accept the surgical indication and have signed the informed consent for the procedure
- No objection from the patients to participate in the study after reading the information sheet
Exclusion criteria
- \- Pregnant or breastfeeding patients
- Life expectancy of less than 2 years
- Patients who have undergone colpocleisis surgery
- Patients with neurological conditions causing loss of sensation
- Patients reporting no interest in sexual activity
- Patients suffering from chronic pelvic pain
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Tenon, service d'urologie — Paris
Identifiers
NCT: NCT07399509 · APHP251272 · 2025-A01903-46